FDA rule prohibits Bay Area woman from artificial insemination

D.C.-based nonprofit group Cause of Action filed suit in California last week against the Food and Drug Administration on behalf of a Bay Area woman, claiming “the FDA is trying to define a personal relationship and regulate individuals’ intimate decisions.”

The Bay Area woman, who filed the suit anonymously under name Jane Doe, wished to conceive a child through artificial insemination. Due to strict FDA regulations over distribution of human cells and tissue, however, she is not allowed to conceive a child in the way she wishes, despite a private, pre-existing agreement with the sperm donor.

“Cause of Action argues that the right to procreate is fundamental and one that cannot be regulated by a government agency,” the group said in a release.

The FDA has very explicit rules over the manufacturing and distribution and usages of human cells and tissue. The problem is that even a noncommercial actor, a person acting outside a formal sperm bank, is subject to the same set of regulatory standards as a sperm bank.

The attorney for the case, Amber Abassi, told The Daily Caller News Foundation that “this is a really interesting example of government overregulation.”

“You hear a lot about government’s over-regulation of business, and so this is just one step further on that spectrum where you’ve got individuals being regulated like businesses,” she told TheDCNF. “What they are doing is one of the most like personal, individual, intimate, decisions that you can make, that’s as far from you know the stream of commerce, as you can get.”

Abassi noted that the sensitivity and intimacy of the issue make it hard to know how many people have been affected by the FDA rule.

“This is clearly not the only example of this,” Abassi said, “But she is the only person who has been willing to, so far, to step forward and to say she wants to stand up for her rights in court.”

“One thing they [the FDA], and this was addressed in our complaints, have guidelines for, is the selection of donors,” Abassi continued. “If you wanted a donor with a particular set of characteristics, you may or may not be able to find that donor in the banks that follow the FDA guidelines.”

“They discriminate by age, they discriminate on the basis of sexual orientation, it’s really a very very, appalling set of regulations. That kind of select for certain aspects of the gene pool.”

Abassi made clear, however, the distinction between those running a business versus those working outside any official organization.

“These regulations are usually applied and rightfully so, in our opinion, to commercial enterprises like a sperm bank, a fertility clinic,” she noted. “But all of them are running as a business.”

“I think it only was made clear to the FDA recently that individuals are doing this for themselves. And so then they said, ‘Oh, well if you read these regulations broadly, they cover the conduct that individuals are also engaging in, regardless of whether that was the intent of the regulation or not.’”

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